Approval of AI-Based Medical Devices in China From 2020 to 2025: Retrospective Analysis.

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Abstract

Artificial intelligence-based medical devices (AIMDs) have emerged as transformative technologies in modern health care. However, comprehensive analysis of recent approval trends and characteristics of AIMDs in China remains limited. This study aimed to provide an up-to-date overview of AIMDs approved in China up to June 2025. We conducted a search of the Drugdataexpy database to identify AIMDs approved up to June 30, 2025, using artificial intelligence-related keywords in the "structural composition" and "intended use" fields. After manual verification and exclusion of non-AIMDs, we collected key characteristics, including name, manufacturer, approval date, risk class, clinical evaluation pathway, medical specialty, data source, review pathway, and algorithm type. Statistical analysis encompassed descriptive statistics and trend analysis. We used the Fisher exact test and Pearson chi-square test to assess the associations between risk class and categorical variables. A total of 154 AIMDs were identified since the first approval in 2020, with annual approvals increasing from 9 in 2020 to 45 in 2024 (a 49.53% compound annual growth rate), although the 20 approvals in the first half of 2025 suggest a potential moderation in pace. Most AIMDs (123/154, 79.9%) were categorized as class III, and the risk class was significantly associated with approval year (P=.03), manufacturer location (P=.03), and medical specialty (P=.004). Of the 123 class III devices, 19 (15.4%) were approved through innovation review, and 2 (1.6%) each were approved through priority and emergency approval. Deep learning was the dominant algorithm (143/154, 92.9%). Radiology dominated the field (106/154, 68.8%), with computed tomography serving as the primary data source (96/154, 62.3%), particularly for applications in pulmonary nodule detection and cardiovascular assessment. Clinical trials were the primary evaluation pathway for 76.6% (118/154) of all AIMDs. This approach was predominant for class III devices (116/123, 94.3%), whereas most class II devices (21/31, 67.7%) used a clinical exemption pathway. Market concentration was evident, with the top 4 manufacturers accounting for 38.3% (59/154) of all approvals and geographically clustered in major innovation hubs such as Beijing, Shanghai, Shenzhen, and Hangzhou. China's AIMD ecosystem is experiencing growth, heavily focused on radiology and computed tomography-based solutions within a risk-proportionate regulatory framework. The market is characterized by significant manufacturer and geographic concentration.

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